(228 days)
SpeediCath Compact Set is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. This device is intended for males only.
The SpeediCath Compact Set is a sterile, ready to use intermittent catheter for males. It is a single use catheter with an integrated urine bag. The catheter is a hollow tube consisting of polyurethane and methylmethacrylate-acrylonitrilebutadiene-styrene polymer [MABS]. It facilitates drainage of urine from the bladder through the urethra to the collection bag. It is available in one size FR/CH 12/18. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) containing polyethylene glycol (PEG) inside a tube. The swelling medium resides between the catheter and the tube and lubricates the catheter.
The provided text describes the 510(k) premarket notification for the "SpeediCath Compact Set" Urological Catheter and Accessories, product number K200820, from Coloplast A/S. This document focuses on demonstrating substantial equivalence to a predicate device (SpeediCath Compact Set, K121458), rather than detailing specific acceptance criteria and a study to prove a device meets those criteria from an AI/algorithm perspective.
The document does not describe an AI/algorithm-based device and therefore does not contain information on:
- Acceptance criteria for an AI algorithm's performance.
- A study proving an AI device meets acceptance criteria.
- Sample size used for an AI test set or its data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods for an AI test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone performance of an AI algorithm.
- Type of ground truth used for AI models.
- Sample size for an AI training set.
- How ground truth for an AI training set was established.
Instead, the document focuses on the substantial equivalence of a physical medical device (a urological catheter) based on non-clinical performance testing.
Here's a summary of the non-clinical performance testing for the SpeediCath Compact Set, as described in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a table of specific numerical acceptance criteria (e.g., a specific coefficient of friction value) and reported performance against those. Instead, it indicates that testing was conducted per applicable standards and that "the results were acceptable."
| Test Category | Standard/Method | Reported Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1:2018; FDA Guidance "Use of International Standard ISO 10993-1" (2016) | Acceptable |
| Cytotoxicity | (Included in Biocompatibility) | Acceptable |
| Irritation | (Included in Biocompatibility) | Acceptable |
| Sensitivity | (Included in Biocompatibility) | Acceptable |
| Chemical Characterization | (Included in Biocompatibility) | Acceptable |
| Coefficient of Friction | ASTM D1894:2014 | Acceptable |
| Corrosion | EN ISO 20696:2018; EN 1616:1997 | Acceptable |
| Shelf Life | ASTM F1980-16 (Accelerated and Real-Time aged) | Acceptable |
| Sterilization Dose Setting | ISO 11137-1:2015; ISO/TS 13004:2013 | Acceptable |
| Impact of Swelling Medium Modification: | ||
| Catheter coating - finger test | Established methods | Acceptable |
| Catheter coating dry out in air | Established methods | Acceptable |
| Catheters, objective friction measurement | Established methods | Acceptable |
| pH of the swelling medium | Established methods | Acceptable |
| Osmolality of the swelling medium | Established methods | Acceptable |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text for any of the tests.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided. The tests described are non-clinical, laboratory-based performance tests, not clinical evaluations requiring expert interpretation of ground truth in the context of an AI device.
4. Adjudication method for the test set:
- This information is not applicable and not provided, as the tests are non-clinical.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI device.
7. The type of ground truth used:
- Not applicable, as the tests are non-clinical hardware performance evaluations against established physical/chemical standards, not against "ground truth" as it would be defined for an AI diagnostic or predictive model (e.g., pathology, outcomes data, expert consensus). The "ground truth" here is effectively the established engineering and biological standards.
8. The sample size for the training set:
- Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI device.
Conclusion from document: The document concludes that "The performance testing demonstrates the subject device is as safe and as effective as the predicate device." This is the basis for the FDA's substantial equivalence determination for this physical medical device.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.